Acetaminophen, When Taken as Directed, Appears Safe for Patients with Liver Disease

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DGNews

Acetaminophen, When Taken as Directed, Appears Safe for Patients with Liver

Disease

FT. WASHINGTON, PA -- March 17, 2005 -- Contrary to common perception,

clinical data demonstrate that acetaminophen is an appropriate pain relief

choice for patients with chronic liver disease. According to a systematic

literature review of the data, which is published in the current issue of

the American Journal of Therapeutics, there is no evidence that

acetaminophen at therapeutic doses aggravates liver disease.

Studies showed that patients with liver disease are able to metabolize

acetaminophen appropriately. The review article concludes that acetaminophen

at recommended doses, when taken as directed, can be used safely in patients

with liver disease and is a preferred analgesic because it lacks the

gastrointestinal toxicity, renal toxicity, and inhibitory actions on

platelet aggregation associated with aspirin and other nonsteroidal

anti-inflammatory drugs (NSAIDs).(1)

" The results of this review refute the popular misconception that liver

disease patients should avoid using acetaminophen to manage their pain, "

said lead author Dr. Gordon Benson, Professor Emeritus, Department of

Medicine, University of Medicine and Dentistry of New Jersey- Wood

Medical School. " Liver toxicity with acetaminophen appears to occur

only in those who consume an overdose of the drug. "

The studies included in the systematic literature review demonstrated:

* Administration of the maximum recommended dose (4 g / d) of acetaminophen

for 13 days to 20 patients with stable chronic liver disease did not result

in any evidence of toxicity.(2)

* In patients with chronic hepatitis C, administration of acetaminophen (3

g/d for seven days) did not affect serum levels of alanine aminotransferase

(a common liver function test).(3)

* Repeated administration of the maximum recommended acetaminophen dose for

over five days to six patients with chronic liver disease did not lead to

accumulation.(4)

* Available studies in patients with chronic liver disease have shown that

although the half-life of acetaminophen may be prolonged, cytochrome P-450

(CYP2E1) enzyme activity is not increased and glutathione stores are not

depleted to critical levels in patients taking recommended doses.

Alcohol-associated acetaminophen hepatotoxicity has not been reported in

prospective studies of alcoholics taking therapeutic doses of acetaminophen.

To date, there have been no prospective studies evaluating use of

acetaminophen in chronic drinkers with underlying liver disease.

" These study data provide a better understanding of how patients with liver

disease are able to metabolize acetaminophen, without increased risk of

hepatotoxicity, " said Dr. Benson. " For liver disease patients who don't want

to risk the side effects of NSAIDs, acetaminophen is a superior pain

management choice. "

Acetaminophen is a commonly used analgesic/antipyretic that is recommended

for management of mild-to-moderate pain and fever. It has been available

without a prescription for almost 50 years in the United States.(5) It is

widely accepted that acetaminophen is safe and well tolerated at recommended

doses. Its analgesic and antipyretic efficacies are generally considered

equivalent to those of aspirin. (6)

References: (1) Benson GD, Koff RS, Tolman KG. Therapeutic use of

acetaminophen in patients with liver disease. Am J Ther. 2005; 12(2):

133-141.

(2) Benson GD. Acetaminophen in chronic liver disease. Clin Pharmacol Ther.

1983;33:95-101.

(3) Dargere S, Collet T, Crampon D, et al. Lack of toxicity of acetaminophen

in patients with chronic hepatitis C: a randomized controlled trial.

Gastroenterology. 2000;118:A947.

(4) Benson GD. Acetaminophen in chronic liver disease. Clin Pharmacol Ther.

1983;33:95-101.

(5) Prescott LF. Paracetamol: past, present and future. Am J Ther. 2000;

7:143-147.

(6) Benson GD, Koff RS, Tolman KG. Therapeutic use of acetaminophen in

patients with liver disease. Am J Ther. 2005; 12(2): 133-141.

SOURCE: McNeil Consumer & Specialty Pharmaceuticals

-------------------

*Note: McNeil Pharmaceuticals is the maker of Tylenol

[Guest guest]

DGNews

Acetaminophen, When Taken as Directed, Appears Safe for Patients with Liver

Disease

FT. WASHINGTON, PA -- March 17, 2005 -- Contrary to common perception,

clinical data demonstrate that acetaminophen is an appropriate pain relief

choice for patients with chronic liver disease. According to a systematic

literature review of the data, which is published in the current issue of

the American Journal of Therapeutics, there is no evidence that

acetaminophen at therapeutic doses aggravates liver disease.

Studies showed that patients with liver disease are able to metabolize

acetaminophen appropriately. The review article concludes that acetaminophen

at recommended doses, when taken as directed, can be used safely in patients

with liver disease and is a preferred analgesic because it lacks the

gastrointestinal toxicity, renal toxicity, and inhibitory actions on

platelet aggregation associated with aspirin and other nonsteroidal

anti-inflammatory drugs (NSAIDs).(1)

" The results of this review refute the popular misconception that liver

disease patients should avoid using acetaminophen to manage their pain, "

said lead author Dr. Gordon Benson, Professor Emeritus, Department of

Medicine, University of Medicine and Dentistry of New Jersey- Wood

Medical School. " Liver toxicity with acetaminophen appears to occur

only in those who consume an overdose of the drug. "

The studies included in the systematic literature review demonstrated:

* Administration of the maximum recommended dose (4 g / d) of acetaminophen

for 13 days to 20 patients with stable chronic liver disease did not result

in any evidence of toxicity.(2)

* In patients with chronic hepatitis C, administration of acetaminophen (3

g/d for seven days) did not affect serum levels of alanine aminotransferase

(a common liver function test).(3)

* Repeated administration of the maximum recommended acetaminophen dose for

over five days to six patients with chronic liver disease did not lead to

accumulation.(4)

* Available studies in patients with chronic liver disease have shown that

although the half-life of acetaminophen may be prolonged, cytochrome P-450

(CYP2E1) enzyme activity is not increased and glutathione stores are not

depleted to critical levels in patients taking recommended doses.

Alcohol-associated acetaminophen hepatotoxicity has not been reported in

prospective studies of alcoholics taking therapeutic doses of acetaminophen.

To date, there have been no prospective studies evaluating use of

acetaminophen in chronic drinkers with underlying liver disease.

" These study data provide a better understanding of how patients with liver

disease are able to metabolize acetaminophen, without increased risk of

hepatotoxicity, " said Dr. Benson. " For liver disease patients who don't want

to risk the side effects of NSAIDs, acetaminophen is a superior pain

management choice. "

Acetaminophen is a commonly used analgesic/antipyretic that is recommended

for management of mild-to-moderate pain and fever. It has been available

without a prescription for almost 50 years in the United States.(5) It is

widely accepted that acetaminophen is safe and well tolerated at recommended

doses. Its analgesic and antipyretic efficacies are generally considered

equivalent to those of aspirin. (6)

References: (1) Benson GD, Koff RS, Tolman KG. Therapeutic use of

acetaminophen in patients with liver disease. Am J Ther. 2005; 12(2):

133-141.

(2) Benson GD. Acetaminophen in chronic liver disease. Clin Pharmacol Ther.

1983;33:95-101.

(3) Dargere S, Collet T, Crampon D, et al. Lack of toxicity of acetaminophen

in patients with chronic hepatitis C: a randomized controlled trial.

Gastroenterology. 2000;118:A947.

(4) Benson GD. Acetaminophen in chronic liver disease. Clin Pharmacol Ther.

1983;33:95-101.

(5) Prescott LF. Paracetamol: past, present and future. Am J Ther. 2000;

7:143-147.

(6) Benson GD, Koff RS, Tolman KG. Therapeutic use of acetaminophen in

patients with liver disease. Am J Ther. 2005; 12(2): 133-141.

SOURCE: McNeil Consumer & Specialty Pharmaceuticals

-------------------

*Note: McNeil Pharmaceuticals is the maker of Tylenol